Pharma serialization — challenging months ahead

04.09.2018
Serialisointi

When the EU Delegated Act (2016/161) on safety features of medicinal products was published in Feb 9, 2016, one would have assumed the industry to be already in full work to get ready by the deadline. This was actually true for the big pharma. Companies having 100+ pharma packaging lines just had to begin work well in advance to have any chance to meet the deadline. The small and medium-sized (SME) manufacturers have been another story.

In August 2018, European Medicines Verification Organization (EMVO) announced that only 841 pharma companies had at least initiated the process to connect to the European Medicines Verification System (EMVS) by signing the agreement with EMVO. This was up only from 500 companies last February, so for most of the about 2240 marketing authorization holders there is a lot left to do. Everyone won’t meet the deadline.

With the big pharma in line as also most of the middle-sized companies, a great majority of the production capacity will be serialized and connected to EMVS in time, thus most drug production will not experience regulatory problems. Some of the small manufacturers producing essential and difficult to replace special medicines may not compliant by the deadline, resulting in a danger of medicine shortages. On the other side, small pharma manufacturers of generics will be in serious trouble if not compliant in time.

I am not a lawyer, but to me it seems that the Falsified Medicines Directive (2011/62/EU, ”FMD”) leaves overseeing the compliance of the pharma manufacturers to the member states. The penalties for non-compliance should be ”effective, proportionate and dissuasive” and ”not be inferior to those applicable to infringements of national law of similar nature and importance.”

It looks to me that this will make many a lawyer happy in the following years.

As an automation integrator with special skills in implementing pharmaceutical serialization, Servicepoint has seen the surge of requests for quotation from SME pharma manufacturers. To respond to the rapidly rising demand we have been recruiting and training more personnel for the specialist tasks. We are happy to help new clients, too. With the current high demand, spending time in tender processes is not a priority, however.

Russian regulatory developments

The Russian pharmaceutical traceability law is going forward with a deadline just eleven months after the EU FMD deadline. The technical specs are still evolving, but case-level aggregation is required by the law for the full traceability service. This should be noted by European manufacturers who, in addition to supplying the European market, export medicines to Russia.

On technical level, the tentative Russian specification spells some trouble for packaging lines. The requirement (see post by Dirk Rodgers) to include a 4-character key (Application Identifier 91) and 88-character encrypted signature (AI 92) to the data matrix, in addition to the (possibly) standard 14-digit GTIN-14 (AI 01) and 13-character serial number (AI 21), results in 122 characters (includes field termination characters). This is considerably more than the 60 digits enough for the EU FMD -compliant data matrix (about 70 with national reimbursement number), resulting in quite a large data matrix (36×36).

Why would this be trouble at the packaging line? As the standard, easy, way to print the data matrix and human readable information is a 12,7 mm wide inkjet printer head, there is a limit how large a square data matrix one can easily print. Making the dot size smaller is possible, but the smaller the dot size, the more difficult (i.e., expensive) it is to reach the required print quality.

Summed up, it sure looks we are going to have an interesting working year ahead, with lots of work needed for the pharma industry to be compliant. Following the regulatory developments is of paramount importance, especially as the Brexit is looming early next year, too.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Iiro Jantunen
TkT, Teknologiajohtaja
Servicepoint Oy
iiro.jantunen@servicepoint.fi
+358 44 7868 215